Cohort study on obesity and nutrition using artificial intelligence

Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

This study is trying to see how nutrition affects obesity by following 500 people with obesity and a smaller group of healthy individuals over five years.

Quick facts

• Study type: Observational
• Enrollment: 650 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yonsei University (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT05494138 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a prospective cohort of obese individuals and a control group to investigate the relationship between nutrition and obesity over a five-year period. The study will enroll 500 obese participants and 30 control participants annually, conducting yearly examinations, blood tests, and clinical event follow-ups. The obese group will be monitored for chronic diseases such as cardiovascular disease and diabetes, while the control group will undergo baseline surveys and annual follow-ups. After five years, only clinical event follow-ups will continue for both groups.

Who should consider this trial

Good fit: Ideal candidates include adults aged 19 and older who are obese with chronic diseases or those with a normal BMI of 18.5 to 24.9.

Not a fit: Patients with serious non-cardiovascular diseases, pregnant individuals, or those with acute conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the nutritional factors influencing obesity and related chronic diseases, potentially leading to improved management strategies.

How similar studies have performed: While similar cohort studies have been conducted, this specific approach integrating artificial intelligence with nutrition and obesity is relatively novel.

Eligibility criteria

Inclusion criteria for the obese group

1. Adults 19 years of age or older
2. Obese patients with chronic diseases such as cardiovascular disease, hypertension, diabetes, and metabolic syndrome (BMI ≥ 25 kg/m2, \[BMI ≥ 30 kg/m2, including 10% or more\])

Inclusion criteria for the control group

1. Adults 19 years of age or older
2. Those with BMI 18.5\~24.9 kg/m2

Exclusion criteria for the obese group

1. Serious non-cardiovascular disease with life expectancy less than 6 months
2. Pregnant or suspected of being pregnant or are lactating
3. Patients within 3 months of organ transplantation
4. Patients currently being treated for acute transplant rejection
5. Patients treated for acute coronary syndrome (myocardial infarction, unstable angina) and discharged within 6 months
6. Patients with acute cerebral infarction within 6 months of being hospitalized and discharged
7. Type 1 Diabetes
8. Patients taking steroids, female hormones
9. Those who have difficulty using smartphones

Exclusion criteria for the control group

1. Serious non-cardiovascular disease with life expectancy less than 6 months
2. Pregnant or suspected of being pregnant or are lactating
3. Persons who are continuously taking medications prescribed by a doctor due to chronic diseases excluding hypertension and dyslipidemia
4. Within 5 years of diagnosis of malignant tumor
5. Those who have difficulty using smartphones

Where this trial is running

Seoul

• Yonsei University Health System, Severance Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Sungha Park — Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
• Study coordinator: Sungha Park

Conditions: Obesity